The following data is part of a premarket notification filed by Deroyal with the FDA for Deroyal Surgical, Umbilicup.
| Device ID | K020753 |
| 510k Number | K020753 |
| Device Name: | DEROYAL SURGICAL, UMBILICUP |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | DEROYAL 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Audrey Daniels |
| Correspondent | Audrey Daniels DEROYAL 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | KSR |
| CFR Regulation Number | 864.9100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-07 |
| Decision Date | 2002-06-13 |